Manufacturing Associate (I – IV)

Post

Position Summary

The Manufacturing Associate will work within the Manufacturing Department and be responsible for daily execution of tasks associated with the manufacture of cell culture products produced by Gemini in accordance with cGMPs. Our products are made aseptically and are sterile-filled following cGMPs. In addition, this person may be asked to assist, and/or perform tasks outside of direct product manufacturing, such as cleaning the manufacturing spaces or to execute maintenance, calibration or validation protocols. This person will be expected to follow, and at times write and implement standard operating procedures (SOPs), work instructions (WIs) and device history records (DHRs) following FDA, USDA, and/or other applicable international guidance documents. This person will always be expected to collaborate as a team player with personnel in EHS, Engineering, Supply Chain, Quality Control, Quality Assurance and Information Technology to effectively perform duties of manufacturing within Gemini.

Reporting Relationships

Direct Supervisor: Sr. Manager, Manufacturing

Indirect Supervisors: Chief Operating Officer

Key Responsibilities

  • Abide by all safety requirements as defined by the company
  • Read and follow all Company SOPs and guidelines
  • Document all work as required by cGMPs on a real time basis
  • Assist with or lead Deviation investigations/closures, CAPA closures or Change Controls
  • Assist with clean room sanitization as required
  • Pass and sustain aseptic qualifications which consist of passing gown qualification, maintaining gown access, passing Grade A qualifications, passing media fill qualifications, and perform Environmental monitoring during aseptic filling
  • Perform aseptic production operations and validations
  • Assist with facility and process validations as required
  • Assist with facility cleaning, operational maintenance or calibration
  • Production, filling and inspection of manufactured formulations
  • All other task assigned to you by direct supervisor

Skills/Abilities

  • Basic knowledge of the Scientific Method
  • Basic math skills, including simple algebra
  • Basic knowledge of and adherence to cGMP
  • Basic knowledge of chemistry and biology
  • Basic knowledge of steam/dry heat sterilization theories
  • Basic knowledge of OSHA Safety requirements
  • Basic level of mechanical aptitude
  • Good documentation skills
  • Ability to lift / move 40 lbs. overhead
  • Ability to learn how to operate all types of production equipment (I.e. Autoclave, Dry Heat Oven, etc.)
  • Ability to read, understand and accurately follow company SOPs and guidelines

Personal Attributes

  • Displays understanding of and promotes company and customer objectives
  • Readily adapts to changing job duties
  • Works well in a team environment
  • Detail oriented
  • Willing to learn new tasks, skills
  • Responds quickly to assignments
  • Positive attitude

Required Skills and Experience

  • Degree or relevant experience in a technical, engineering or science-based discipline
  • Preferred > 1-year relevant experience in a biopharmaceutical manufacturing facility or equivalent experience in a current Good Manufacturing Practices (cGMP) or technical manufacturing environment
  • Knowledge of general, technical and manufacturing operations
  • A proven ability to work as part of a team to deliver results
  • Organization Skills – Ability to manage multiple priorities and know when to escalate issues for resolution
  • Effective Communicator
  • Basic level of understanding with Microsoft Office Products (Word, Excel)

Company Values

  • Customer Focus
  • Integrity
  • Quality
  • Respect
  • Commitment
  • Empowerment

Job Type: Full-time

Experience:

  • Working experience with record of good performance: 4 years (Preferred)
  • cGMP: 2 years (Preferred)
  • Microsoft Office: 2 years (Preferred)

Education:

  • Bachelor’s (Preferred)

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